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The purpose of this study is to determine if an additional injection of local anesthetic immediately prior to removal of the local anesthetic infiltration catheter on postoperative day one is effective in increasing pain reduction, patient satisfaction or outcome measures following total knee replacement (TKR). It is hypothesized that an additional injection of 30ml of .5% bupivacaine solution immediately before infiltration catheter removal will provide pain reduction, patient satisfaction and outcome measures equal or superior to catheter removal with no additional injection.
Patients who are undergoing unilateral total knee replacement (TKR) and choose to participate will be randomly assigned to a treatment group.Patients in group one (treatment group) will receive a 30ml dose of .5% bupivacaine solution injected into the local anesthetic infiltration catheter immediately prior to its removal on postoperative day one. Patients in group two (control group) will receive no additional medication during local anesthetic infiltration catheter removal.
The purpose of this study is to determine if an additional injection of local anesthetic immediately prior to removal of the local anesthetic infiltration catheter on postoperative day one is effective in increasing pain reduction, patient satisfaction or outcome measures following total knee replacement (TKR). It is hypothesized that an additional injection of 30ml of .5% bupivacaine solution immediately before infiltration catheter removal will provide pain reduction, patient satisfaction and outcome measures equal or superior to catheter removal with no additional injection. The target enrollment for this study is 50 participants, 25 in each of groups one and two.
Patients who are undergoing unilateral total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. Upon agreement, patient's consent will be obtained and they will be randomly assigned to a treatment group. Patients in group one (treatment group) will receive a 30ml dose of 0.5% bupivacaine solution injected into the local anesthetic infiltration catheter immediately prior to its removal on postoperative day one. Patients in group two (control group) will receive no additional medication during local anesthetic infiltration catheter removal.
Members of both groups will be asked to complete Visual Analog Scale (VAS) pain and satisfaction surveys and also to track daily narcotic pain medication consumption during the first week postoperatively. Measures of swelling in the operative knee will be collected for members of both groups at the first routine postoperative appointment approximately one week after surgery. Swelling will be measured using a Perometer which calculates the total volume of the extremity in cubic centimeters (Pero-System, Wuppertal, Germany). Proprioception will be measured using a SD Balancer (Biodex Medical Systems, Shirley, NY) which calculates the the overall stability index (OSI) and compares it to age standardized data. Quadriceps strength using a handheld dynamometer. Outcome measures will be collected for members of both groups prior to surgery and at the second routine postoperative appointment between 6 weeks after surgery. Swelling will be also measured at the first post-operative visit 1 week after surgery. These data measures, as well as any complications will be recorded and used for analysis at the completion of the study.
The Principal Investigator (PI) will review all pain, satisfaction, narcotic usage and proprioception data on a weekly basis with the research assistant (RA) as it is collected. These checks will help to ensure validity and patient safety. Privacy and confidentially will be assured by using codes as deidentifiers in place of identifying information on any data sheets used in analysis. Data which identifies the patient will be made available only to investigators and stored only in a private folder on department computers protected with a firewall. No data will be shared outside of Partners. Adverse events will be promptly reported to the PHRC as per PHRC rules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection | Experimental | Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal |
|
| No Injection | Active Comparator | Will not receive injection of bupivacaine prior to catheter removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Injection of local anesthetic immediately prior to catheter removal, 24 hours postop. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessed Using the VAS 0-10 Pain Scale | Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Med Consumption Assessed Using Questionnaire/Hospital Records | Questionnaire/Hospital Records - While patients are in the hospital, pain medication consumption will be tracked in their electronic medical record. At home, patients will be asked to keep a log of pain medication consumption. They will be asked to record this information on a questionnaire at their first post-operative visit. | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
• Bilateral TKA planned
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Fitz, MD | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23516031 | Background | Chaumeron A, Audy D, Drolet P, Lavigne M, Vendittoli PA. Periarticular injection in knee arthroplasty improves quadriceps function. Clin Orthop Relat Res. 2013 Jul;471(7):2284-95. doi: 10.1007/s11999-013-2928-4. Epub 2013 Mar 21. | |
| 24911869 | Background | Barrington JW, Halaszynski TM, Sinatra RS, Expert Working Group On Anesthesia And Orthopaedics Critical Issues In Hip And Knee Replacement Arthroplasty FT. Perioperative pain management in hip and knee replacement surgery. Am J Orthop (Belle Mead NJ). 2014 Apr;43(4 Suppl):S1-S16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Injection | Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop. |
| FG001 | No Injection | Will not receive injection of bupivacaine prior to catheter removal No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Injection | Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop. |
| BG001 | No Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Assessed Using the VAS 0-10 Pain Scale | Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain. | Posted | Mean | Full Range | units on a scale | 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injection | Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wolfgang Fitz | Brigham and Women's Hospital | 6177329501 | wfitz@partners.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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We randomized 50 patients undergoing TKA at one institution into two groups. Group 1, 25 patients, received a postoperative intra-articular catheter in combination with injection of 30 ml of 0.5% Marcaine the day after surgery before removal. Group 2, 25 patients, received no pain catheter. Both groups received intraoperative pericapsular injection and postoperative pain medication. We measured pain scores using the Visual Analog Scale (VAS) and recorded narcotic medication consumption in morphine milligram equivalents (mgs).
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| No Intervention | Other | No injection of local anesthetic immediately prior to catheter removal, 24 hours postop. |
|
| Pain Med Consumption Assessed Using Questionnaire/Hospital Records | Total pain medications consumed by the patient, determined through the patients' own records in the questionnaire as well as hospital records of pain med administration and prescription. | 7 days |
| Swelling Measured Using a Perometer | Swelling in the affected TKR joint, as measured by a perometer. | 7 days |
| Proprioception Measured Using a SD Balancer | Proprioception measured after surgery, as measured by an SD balancer. | 7 days |
| Quadriceps Strength Measured Using a Biodex Handheld Dynamometer" | Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer. | 7 days |
| 23783531 | Background | Teng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20. |
| 23910819 | Background | Jiang J, Teng Y, Fan Z, Khan MS, Cui Z, Xia Y. The efficacy of periarticular multimodal drug injection for postoperative pain management in total knee or hip arthroplasty. J Arthroplasty. 2013 Dec;28(10):1882-7. doi: 10.1016/j.arth.2013.06.031. Epub 2013 Aug 1. |
| Background | National Center for Health Statistics. National Hospital Discharge Survey, 2010. Hyattsville, Maryland: Public Health Service. 2010. |
Will not receive injection of bupivacaine prior to catheter removal
No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain Med Consumption Assessed Using Questionnaire/Hospital Records | Questionnaire/Hospital Records - While patients are in the hospital, pain medication consumption will be tracked in their electronic medical record. At home, patients will be asked to keep a log of pain medication consumption. They will be asked to record this information on a questionnaire at their first post-operative visit. | Posted | Mean | Full Range | morphine milligram equivalents (mgs) | 2 days |
|
|
|
| Secondary | Pain Med Consumption Assessed Using Questionnaire/Hospital Records | Total pain medications consumed by the patient, determined through the patients' own records in the questionnaire as well as hospital records of pain med administration and prescription. | Data were not collected. | Posted | 7 days |
|
|
| Secondary | Swelling Measured Using a Perometer | Swelling in the affected TKR joint, as measured by a perometer. | Data were not collected. | Posted | 7 days |
|
|
| Secondary | Proprioception Measured Using a SD Balancer | Proprioception measured after surgery, as measured by an SD balancer. | Data were not collected. | Posted | 7 days |
|
|
| Secondary | Quadriceps Strength Measured Using a Biodex Handheld Dynamometer" | Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer. | Data were not collected. | Posted | 7 days |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | No Injection | Will not receive injection of bupivacaine prior to catheter removal No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000588 |
| Amines |